Healthcare Professional User Manual

Smith & Nephew

PICO™ 14

Single Use Negative Pressure Wound Therapy System

User Manual

Product Features:

Quiet Pump: Noise level below 35dB.
Up to 14 Days: System lasts up to 14 days.
High Air Leak Tolerance: Pump has high tolerance to air leaks.
Dressing Full Indicator: Indicates when the dressing is full.
Airlock Layer: Helps maintain negative pressure across the dressing.
Silicone Adhesive Dressing: Features a silicone gel adhesive.
Showerproof Dressing: The dressing is showerproof.
Exudate Evaporation: Up to 80% of exudate managed through evaporation.
Low to Moderate Exudate: Indicated for low to moderate exuding wounds.

1. Description

The PICO™ 14 Single Use Negative Pressure Wound Therapy System is intended for use by or under the direction of a trained and licensed physician. This manual is for healthcare professionals only. The system consists of a pump, extension tube, batteries, sterile dressings, and fixation strips. The PICO 14 pump maintains negative pressure wound therapy at 80 mmHg (nominal) to the wound surface. Exudate is managed by the dressing through absorption and evaporation. The soft port has an integrated filter to prevent liquid ingress. The system is intended for use for up to 14 days on low to moderately exuding wounds. For low exuding wounds, each dressing is intended for up to 7 days. For moderately exuding wounds, each dressing is intended for up to 4 days. Additional dressings may be required for 14-day use on moderate exuding wounds. Low exuding wounds are defined as up to 0.6g of liquid exudate/cm² of wound area/24 hours. Moderate exuding wounds are defined as up to 1.1g of liquid exudate/cm² of wound area/24 hours. The PICO System has been demonstrated to be effective for up to 7 days in reducing the incidence of surgical site infection.

2. Indications

The PICO 14 System is indicated for patients who would benefit from negative pressure wound therapy (NPWT) to promote wound healing by removing low to moderate levels of exudate and infectious materials. It is suitable for use in hospital and homecare settings. Appropriate wound types include:

Chronic wounds
Acute wounds
Traumatic wounds
Subacute and dehisced wounds
Partial-thickness burns
Ulcers (e.g., diabetic or pressure ulcers)
Venous leg ulcers (can be used with graduated compression therapy)
Flaps and grafts
Closed surgical incisions

When used on closed surgical incisions for up to 7 days, the PICO 14 System is intended to aid in reducing the incidence of:

Superficial and deep incisional surgical site infections for high-risk patients in Class I and II wounds.
Post-operative seroma.
Dehiscence.

Note: Safety and effectiveness for Class III (contaminated) and Class IV (dirty/infected) wounds have not been demonstrated. The device is not intended to reduce organ space surgical site infections. The use of PICO does not preclude the need for a comprehensive infection management protocol.

3. Contraindications

The PICO 14 System is contraindicated for:

Patients with malignancy in the wound bed or margins (except in palliative care).
Previously confirmed and untreated osteomyelitis.
Non-enteric and unexplored fistulas.
Necrotic tissue with eschar present.
Exposed arteries, veins, nerves, or organs.
Exposed anastomotic sites.

The PICO 14 System should not be used for:

Emergency airway aspiration.
Pleural, mediastinal, or chest tube drainage.
Surgical suction.

4. PICO 14 System with graduated compression therapy

The PICO 14 System with graduated compression therapy may be used to treat venous ulcerations. Refer to section 10.2 for application details.

5. Important Information

Pump Placement Warning: The PICO 14 pump contains a MAGNET. Keep the PICO 14 pump at least 4 inches (10 cm) away from other medical devices at all times to prevent disruption of their operation. See Section 6 for Magnet Warning details.

For information on electromagnetic immunity and emissions, refer to Section 15.

6. Warnings

Magnet Warning: The PICO 14 pump contains a magnet. Maintain a minimum distance of 4 inches (10 cm) from other medical devices, including pacemakers, ICDs, shunt valves, neurostimulators, insulin pumps, and cochlear implants. This applies to both patients and caregivers.
Bleeding Risk: Patients at high risk of bleeding complications must be closely monitored. If sudden or increased bleeding is observed, disconnect the pump, leave the dressing in place, take measures to stop bleeding, and seek immediate medical assistance.
Hemostasis and Anticoagulants: Hemostasis must be achieved before applying the dressing. Patients on anticoagulant therapy have an increased risk of bleeding. Avoid hemostatic products that may increase bleeding risk if disrupted. Frequent assessment is necessary.
Pump Positioning: Ensure the pump, tubing, and connectors do not cause pressure damage, present a trip hazard, become contaminated, cause strangulation, rest on heat sources, or become twisted/trapped.
Wound Preparation: Cover or remove sharp edges or bone fragments before use to prevent puncturing organs or blood vessels.
Defibrillation: If defibrillation is required, remove the dressing if it interferes with the procedure.
MRI Safety: The PICO 14 pump is MR Unsafe. Remove the pump before entering an MRI suite. Do not bring the pump into the MRI scan room due to projectile hazard.
Pediatric Use: Safety and effectiveness in pediatric patients (<22 years old) have not been evaluated. Consider patient size and weight.
Explosion Risk: Do not use in areas with explosion danger (e.g., hyperbaric oxygen units).
Choking Hazard: The PICO 14 System contains small parts. Keep out of reach of children.
Flammable Anesthetics: Not suitable for use with flammable anesthetic mixtures.
Dressing Application: PICO dressings should only be applied, changed, or removed by a healthcare professional.
Single Wound Use: Each PICO dressing must be used for only one wound.
Animal Hazards: Keep the system away from pets, pests, and other animals that could damage it.
No Modifications: No modification of this equipment is allowed.
Combination Therapy: When using with graduated compression therapy, comply with indications and contraindications for both products.

7. Precautions

High-Risk Patients: Take precautions for patients at high risk of bleeding complications, including those on anticoagulant therapy, with weakened blood vessels, difficult wound hemostasis, malnutrition, or those who are non-compliant or combative. Use caution in wounds near blood vessels or delicate fascia.
Adverse Signs: If pain, reddening, odor, sensitization, or a sudden change in wound fluid occurs, contact a healthcare professional immediately.
Skin Grafts: Regularly inspect systems used to bolster skin grafts to ensure continuous NPWT and seal maintenance.
Infected Wounds: More frequent dressing changes may be required for infected wounds. Maintain regular wound monitoring.
Ischemic Limbs: Use caution when applying circumferential dressings or NPWT on ischemic limbs to avoid compromising circulation.
Pump Accessibility: The pump lacks audible alerts; carry it accessibly for routine status checks.
Occlusive Materials: Do not apply occlusive materials over the dressing's pad area, as this impairs moisture evaporation.
Rigid Immobilization: Avoid covering PICO dressings with rigid immobilization devices or casts that might apply excessive pressure.
Wound Inspection: Prolonged placement of rigid or opaque materials may prevent regular wound inspection and assessment.
Fragile Skin: Use a skin protectant (e.g., NO-STING SKIN-PREP) on skin areas where fixation strips are applied to prevent skin stripping.
Oil-Based Products: Do not use PICO dressings with oil-based products (e.g., petrolatum) as they can compromise the seal.
Foam Fillers: When using foam fillers, tissue ingrowth may be reduced by using a non-adherent wound contact layer or increasing dressing change frequency.
Surgical Drains: The PICO 14 System may be used with surgical drains, provided the dressing is not placed over the drain exit site.
Fluid Protection: Protect the pump from fluids. Discontinue use if fluid ingress is observed.
Showering/Bathing: Stop and disconnect the pump during showering/bathing. Ensure the tubing end faces down to prevent water entry. Reconnect and restart after the procedure.
Pump Disassembly: Do not take the pump apart.
Dressing Compatibility: Use PICO dressings only with PICO pumps.
Tubing/Port Handling: Do not alter or pull on the tubing or soft port.
Dressing Pad: Do not cut the PICO dressing pad, as this can lead to loss of NPWT.
Dressing Placement: Position the PICO dressing centrally over the wound. Place the soft port uppermost on intact skin, not extending over the wound, to minimize fluid collection around the port.
Electromagnetic Interference: Use caution near electronic equipment like RFID readers or metal detectors.
CT Scans/X-rays: Move the pump out of range if possible. Check system function after exposure.
Single Use: The PICO 14 System is single use only. Reuse may cause cross-contamination. Do not use expired or damaged dressings.
Environmental Factors: High temperatures and humidity may reduce dressing wear times.
Transportation: The system can be used in aircraft, trains, and boats. Exercise caution with pump positioning near others (see magnet warning).
RF Interference: During transport, RF interference may affect pump performance. Replace batteries if malfunction occurs. Contact a healthcare professional if the issue persists.
Dressing Overlap: Ensure dressing borders do not overlap when placed next to each other.
Cavity Use: This device has not been evaluated for abdominal and thoracic cavity use.
Special Care Conditions: Use near the vagus nerve (bradycardia) or with spinal cord injury (sympathetic nervous system stimulation) requires special care.

8. Adverse Reactions

Excessive bleeding is a serious risk. Careful patient selection, monitoring of blood loss, and assessment of exudate changes are essential. Monitor the patient for sudden or abrupt changes in exudate volume or color.

9. Definitions

Definitions for superficial and deep incisional Surgical Site Infections (SSIs) are provided according to CDC 2020 guidelines. A superficial incisional SSI involves skin and subcutaneous tissue within 30 days of a procedure. A deep incisional SSI involves deep soft tissues within 30 or 90 days of a procedure.

Reference: CDC 2020. SSI - Procedure-associated Module 2020. Available from: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf [Accessed 04/11/2020]

10. Instructions for Use

10.1. Guidance on Wound Suitability

PICO dressings should be used on wounds that fit comfortably within the dressing pad area. Soft port positioning is crucial (on intact skin, not over the wound). PICO Multisite dressings enhance conformability for awkward areas. Dressings are for single wound use.

Depth: Wounds generally no more than 4.5 cm (1.77 in.) deep. Fillers may be required for wounds deeper than 0.5 cm (0.2 in.). Avoid exposed arteries, veins, nerves, or organs.
Exudate: Intended for low (up to 0.6g/cm²/24h) to moderate (up to 1.1g/cm²/24h) exudate levels. For moderate exudate, wound size should generally not exceed 25% of the dressing pad area.

10.2. Application

The dressing should only be applied by a healthcare professional.

Remove excess hair for close approximation of the dressing.
Irrigate the wound with sterile saline and pat dry if necessary. Peel off the first release handle, place the dressing centrally over the wound, ensuring it lies flat. Position the port uppermost on intact skin, not over the wound. Remove remaining handles and smooth the dressing, avoiding creases.
Remove the pump and batteries from the tray. Warning: Keep the pump at least 4 inches (10 cm) away from other medical devices.
Insert batteries according to compartment indicators. Replace the cover. All four indicators should illuminate for 3 seconds.
Connect the pump to the dressing tubes by twisting the connectors. The soft tube can connect directly to the pump if long tubing is not required.
Press the orange button to start NPWT. The green 'OK' and orange 'air leak' indicators will flash together (pump establishing therapy). Therapy should be established within 100 seconds. If not, the orange 'air leak' indicator will flash. Refer to Section 16 for troubleshooting.
If using NO-STING SKIN-PREP, wipe the area around the dressing and allow to dry. Apply fixation strips around the dressing border, overlapping by approximately 1 cm (2/5 in.). Remove the top carrier after application. These strips maintain the seal. If fixation strips are removed, the dressing must also be replaced. Gel patches may be used to help maintain the seal.

10.3. Use of the PICO 14 System with graduated compression therapy

The PICO 14 System can be used with compression for venous leg ulcerations. Ensure tubing does not contact skin. When using compression, the flat soft port tubingModels: PICO 14 Single Use Negative Pressure Wound Therapy System, PICO 14, Single Use Negative Pressure Wound Therapy System, Negative Pressure Wound Therapy System

File Info : application/pdf, 4 Pages, 3.77MB

35052 PICO 14 HCP US

References

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